Sr Manager, Training

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life‑saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

The Sr. Manager, Training is a senior Quality leadership role accountable for the end‑to‑end governance, effectiveness, and continuous improvement of the GMP Training program at the Canton, MA GMP vaccine Drug Substance (DS) manufacturing site. The role ensures site compliance with applicable U.S. and international GxP regulations, Emergent Global Quality Standards, and regulatory expectations (e.g., FDA, EMA).

This position serves as the site owner for the Learning Management System (LMS/eLM), with direct responsibility for training program strategy, inspection readiness, and data integrity. The incumbent partners closely with Global Process Owners (GPOs) for Training and related Quality systems to ensure consistent global‑to‑site deployment, effective implementation of system upgrades, and alignment with evolving regulatory and business needs.

The Sr. Manager acts as a key Quality representative for internal and external audits, and supports site leadership by providing actionable KPIs, risk‑based insights, and strategic recommendations to sustain a compliant, inspection‑ready, and agile Quality system.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Own, manage, and continuously improve the site GMP Training Program in alignment with regulatory expectations, Global Standards, and site operations.
• Serve as Site Process Owner (SPO) for LMS/eLM, including system configuration, administration, governance, change management, user access, and data integrity oversight.
• Ensure periodic GMP training, role‑based qualification, and personnel competency programs are implemented, maintained, and inspection‑ready in accordance with CGMP and internal procedures.
• Approve GMP training materials and ensure training content is technically accurate, risk‑based, and appropriate for adult learners, including instructor‑led training, OJT, and electronic learning.
• Partner with Global Process Owners (GPOs) to deploy global processes, system enhancements, integrations, and performance metrics at the site while managing site‑specific impacts and regulatory risks.
• Establish, monitor, and report meaningful KPIs and effectiveness metrics for training compliance, qualification status, document lifecycle performance, and inspection readiness.
• Lead gap assessments, root cause evaluations, and CAPAs related to training; ensure timely and sustainable remediation.
• Ensure job descriptions, curricula, qualifications, and CVs are maintained within employee electronic training records in compliance with regulatory and internal requirements.
• Act as a primary Quality contact for client, internal, and regulatory inspections impacting training systems; participate in inspection preparation, execution, response, and follow‑up.
• Drive continuous improvement initiatives leveraging risk management principles (ICH Q9) and Quality system maturity concepts (ICH Q10).
• Build organizational capability through mentoring, technical development, and cross‑functional collaboration.
• Proactively identify resource needs and advocate for investments required to sustain compliant and scalable systems.
• Partner with site and Quality leadership to embed Quality culture, accountability, and compliance into daily operations.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Education:

• Bachelor's degree in Life Sciences, Education, Engineering, or a related scientific discipline required.
• Master's degree or advanced certification in Quality, Regulatory,…